Healthbeacon, Ltd.
IE Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
HealthBeacon HB2 Sharps Bin Ref K172719
FDA establishments
- Healthbeacon Dublin Dublin(County) · IE FEI 3015222108
What Healthbeacon, Ltd. makes
Healthbeacon, Ltd. manufactures the HealthBeacon HB2 Sharps Bin, a container designed for the safe disposal of used needles and other sharps in clinical settings to prevent accidental punctures and contamination.
The company’s products are regulated as Class II devices under the FDA’s 510(k) clearance pathway and are listed in the FDA’s 510(k) database. Healthbeacon, Ltd. is based in the United States.
Frequently asked questions
What types of medical devices does Healthbeacon, Ltd. manufacture?
Healthbeacon, Ltd. specializes in the manufacture of sharps disposal containers. Their primary product, the HealthBeacon HB2 Sharps Bin, is designed specifically for safely disposing of used needles and other sharps in healthcare environments to reduce the risk of accidental punctures and contamination.
Where is Healthbeacon, Ltd. based?
Healthbeacon, Ltd. is headquartered in the United States. The company’s location in the US aligns with its focus on regulatory compliance under the FDA’s jurisdiction.
How are Healthbeacon, Ltd.’s devices classified by regulatory authorities?
Healthbeacon, Ltd.’s devices, including the HB2 Sharps Bin, are classified as Class II medical devices under the FDA’s regulatory framework. This classification requires premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness before commercial distribution.
Which regulatory registries or databases list Healthbeacon, Ltd.’s devices?
Healthbeacon, Ltd.’s devices are listed in the FDA’s 510(k) database, which catalogs medical devices that have undergone the required premarket notification process. This registry serves as a public reference for authorized Class II devices, including those manufactured by Healthbeacon.
Information
- Country
- IE